Medicines and Healthcare Products Regulatory Agency ("MHRA") - Clinical Practice Research Datalink

Re-engineering of MHRAs (CPRD) Interventional Research Services Platform

4 Incomplete applications

2 SME, 2 large

4 Completed applications

1 SME, 3 large

Published: Friday 20 November 2020
Deadline for asking questions: Friday 27 November 2020 at 11:59pm GMT
Closing date for applications: Friday 4 December 2020 at 11:59pm GMT

Overview

Summary of the work: • Decoupling IRSP application from third party platform, enabling independent operation whilst retaining full functionality by rebuilding and replacing:
o Data delivery platform, navigation, collaboration backbone with common web libraries and database
o STS
o CDN
• Three months of post- implementation support
• Full knowledge transfer to in-house team
Latest start date: Monday 1 February 2021
Expected contract length: MHRA are looking for the work to completed, tested and in production by December 2021
Location: London
Organisation the work is for: Medicines and Healthcare Products Regulatory Agency ("MHRA") - Clinical Practice Research Datalink
Budget range: We expect that this work should cost in the region of £280k (exc vat)

About the work

Why the work is being done: To align with government strategy of using open source and open standard practices whilst adhering to the use of Government Technology Code of Practice such as but not limited to:
• Is easier to share across government
• Easy to maintain
• Scales for the future use
• Less dependent on single third-party supplier

The goal of this work is to untangle
The Clinical Practice Research Datalink ("CPRD") components whilst rebuilding the missing elements to make sure the Interventional Research Services Platform ("IRSP") system function 100% interdependent from any third-party related technology components, whilst retaining its current functionality 100%.
Problem to be solved: The CPRD owned IRSP is closely intertwined with a third party owned platform/framework on which it sits – the extent of this is understood from a recent assessment of the system. There is a need to reengineer the IRSP in order to decouple it and so create an independently-functioning platform by replacing core components and rebuilding the missing pieces. This will enable the IRSP to be fully controlled and owned by CPRD, paving the way for future enhancements of the service. This is back-end work and the current functionality of the IRSP will be maintained.
Who the users are and what they need to do: As the owner of IRSP, CPRD needs this work to be completed so it has full control over the application and the ability to implement any future enhancements. The users of the application are both CPRD’s Interventional Research team and GPs who are assisting with clinical trial recruitment. These users need IRSP to continue to function as it currently does; the changes are back-end and so users should experience no (or very little) difference and not experience any disruption to IRSP performance
Early market engagement: No early market engagement has been undertaken.
Any work that’s already been done: Initial discovery work has been completed. This comprised an assessment of the IRSP to understand the system and document the components which are common with the third-party platform. Consequently, CPRD have a good understanding of what would be required technically to de-couple IRSP from the third-party platform. The assessment and outcomes are detailed in a comprehensive report.
Existing team: The supplier will be working with CPRD's technology team, the Data, Tools and Technology ("DTT") Team. DTT is responsible for the landing, processing and making available of CPRD's data for use by both observational and interventional researchers. DTT consists of data, development, infrastructure and project management expertise.
Current phase: Not applicable

Work setup

Address where the work will take place: London, (10 SC - Canary Wharf). Most likely the work will be done remotely, however, following return to the office post Covid-19, some face to face meetings will be required
Working arrangements: The CPRD project team and other internal key stakeholders will be working with suppliers team remotely in an agile mindset, particularly using SCRUM methodology. Daily stand-ups, sprint planning and retro events are to be conducted appropriately either face-to-face or remotely/virtually.

CPRD will work closely with the supplier to ensure full transfer of knowledge gained during the project.
Security clearance: No additional security clearance required

Additional information

Additional terms and conditions: None

Skills and experience

Buyers will use the essential and nice-to-have skills and experience to help them evaluate suppliers’ technical competence.

Essential skills and experience: Demonstrate a proven track record of designing and developing information systems in a Real-World Evidence Research domain

Please demonstrate your knowledge and experience of working with real-world data to support clinical trials

Demonstrate experience in re-engineering software/applications, i.e. reorganising and modifying legacy software systems based on source codes written/compiled by multiple third-party developers to cloud-native

Demonstratable recent experience in writing web/application using Microsoft technology stack C#, .NET Core, SQL, Java and JavaScript in Real -World Evidence Research domain

Demonstrate experience or knowledge around implementing Identity as a Service (IDaaS) with Azure Active Directory (AAD)

Demonstrate experience in build, test and deploy applications into Cloud environments using CI/CD pipelines • Please demonstrate experience in integrating Salesforce with other applications via API’s

Please demonstrate that you will have the available capacity to support the Statement of Requirements from January 2021 for a duration of 12 months plus

Please demonstrate your experience of working on public sector information system projects delivering them against government digital service standards

Please demonstrate how you would handover knowledge/resources on system to internal staff in specialised and technical roles for post-implementation maintenance and support
Nice-to-have skills and experience: Not applicable

How suppliers will be evaluated

All suppliers will be asked to provide a written proposal.

How many suppliers to evaluate

Proposal criteria

The proposed Technical Solutions fit with the business need
Approach and methodology for delivering the outcomes specified
Extent to which the proposal meets the mandatory requirements
Completion of all work within delivery timeframes
The indentification of risks, assumptions and dependencies and the suppliers proposal for managing them
Price and value for money

Cultural fit criteria

Ability to be transparent and work in collaboration with CPRD’s technical and non-technical teams
Approach to knowledge transfer, upskilling and sharing best practices with CPRD’s internal team members

Payment approach

Capped time and materials

Additional assessment methods

Presentation

Evaluation weighting

Technical competence

70%

Cultural fit

Price

25%

Questions asked by suppliers

1. Please elaborate on the 'additional assessment method' listed as Presentations.: We will invite shortlisted suppliers to give a short presentation detailing their proposed approach to the project. This will be followed with questions from the CPRD team to gauge the suppliers’ suitability to undertake the work. The session will be expected to last for approximately one hour and will be conducted via MS Teams.
2. 3. Wrt question "Please demonstrate that you will have the available capacity to support the Statement of Requirements from January 2021 for a duration of 12 months plus", Please advise an approx. peak team capacity or size of team in terms of range, as anticipated from the supplier to fulfil the statement of requirements from January 2021 to Dec 2021. Please also share the size of Day 1 team and roles if available based on latest information: We expect the first 30 days to be an exercise for the supplier to conduct sprint 0 activities. This phase of work would require further assessment, creation of the backlog, onboarding/review of the development team, and any prototyping if required. We expect critical roles such as solution architect, Agile project coordinator, technical architect, UX designer , QA tester, and developer to be required for a few days/hours within this first month.
3. 4. Do you have any constraints for using offshore delivery or is the delivery to be done in UK only?: There are no constraints for using offshore delivery. However, it is required for the supplier’s team to work deliver during UK business hours
4. Please confirm (1) the different roles (in the scrum team) expected to be fulfilled by supplier and (2) also any specialist/SME roles (like IDaas) which you anticipate during the course of the engagement. Example – we refer to need of IDaaS and infra/security specialist which could be a short term requirement.: 1) Currently the roles we expect to be fulfilled by the supplier to include Agile project coordinator, technical architect(s), solution architect(s) UX designer(s), QA tester(s) and developer(s).

2) Currently the existing system is being migrated as-is to a Cloud environment. Hence for the re-engineering piece of work on STS for user authentication, we would prefer to take advantage of the new IDaaS concept in AAD. In this case, we expect the supplier to have the required knowledge/expertise when it is required.
5. There is a mention of backend work plus minor enhancements / tweakings. Can you elaborate on nature of these enhancements and to possibly deduce indicate size/complexity, a view of number of minor / major enhancements planned ? We assume minor enhancements to need <5 days of overall development effort.: The scope of this piece of work is purely back-end reengineering, and no enhancements are expected. The future enhancements referred to will be part of CPRD’s continuous improvements and are outside the scope of this work.
6. Please share the assessment report.: The assessment report will be shared with shortlisted applicants ahead of the evaluation stage of the process. Further technical details are not required for applicant shortlisting.
7. Please provide the current application and technical architecture supporting the IRSP application and detail on components that need to be rebuild/re-engineered and components which need to be added.: The technical and architectural details will be shared with shortlisted applicants in the assessment report, ahead of the evaluation stage of the process. Further technical details are not required for applicant shortlisting.
8. What is the expected date of contract award? Will there be availability from MHRA staff for a discovery phase to refine the requirements once the contract is awarded prior to starting development?: It is expected that the successful supplier will be informed before the end of December 2020, with the work commencing in by 1st February 2021. The discovery assessment report containing detailed information about the work required and the components to be replaced will be shared with shortlisted suppliers. Moreover, the sprint 0 (circa 30 days) is to be utilised for further assessment, creation of the backlog, onboarding/review of the development team, and any prototyping if required, working along with the internal project/engineering team.
9. Is the solution expected to be entirely cloud based or hosted locally?: Currently the existing on-premise system is being migrated as-is to the cloud environment. The re-engineered system is also to be developed and hosted within the cloud environment, which will the Azure environment.
10. In reference to the requirement that ‘the supplier will be working with CPRD’s technology team’, is the expectation that the supplier overseas all management and implementation of the project while keeping CPRD’s team updated or is there an expectation of embedding any CPRD staff into the delivery team for project management or development?: The latter is the case, as the expectation is to have CPRD staff in specialist roles embedded during development and post implementation. The objective is to have CPRD staff in specialist roles work hand-in-hand with supplier’s engineers where applicable to facilitate transfer of knowledge
11. 11. Hi there, we have extensive.net stack experience. And, have experience delivering real-world data solutions in a clinical research domain. However, the latter was on a different technology stack. Why is it of any relevance that the requirement is married? We can prove beyond a shadow of doubt expertise in both areas and anyone with a technical background will know, therefore, that the marriage is irrelevant. We prove on one hand software design for real-world data including data security, live data, data presentation, integrations, etc. The other we prove that we have extensive.net knowledge. Please explain: The application has been developed using Microsoft technology stack. Hence it is a requirement by the buyer that the supplier has extensive experience in the relevant technology stack in the domain. However, we do note your point, and we would encourage you to point out your skills/exposure in the technology and domain.
12. Wrt question " Please demonstrate how you would handover knowledge/resources on system to internal staff in specialised and technical roles for post implementation maintenance and support", please advise you are expecting framework or experience or both, and confirm that the question is exploring 'how the supplier will handover all knowledge to MHRA Support team in advance of project going live'. We assume supplier team will not be involved in delivery of live services except for the 3 month period for warranty support of changes/code developed.: Preferably, please provide demonstration of both experience and the framework/methodology for how knowledge would be handed over to MHRA internal specialist staff for post-implementation support and maintenance.

The supplier team will responsible for delivery of the re-engineered system to a production state, followed by the standard warranty. However, the three-month period will make sure supplier works hand-in-hand with the in-house specialist team to support and maintain the system post-implementation to ensure the in-house have the necessary skills and knowledge. Such activities are (but not limited to); handling of bugs, problems, and fixing them whilst working with internal specialist team.
13. Can you please elaborate on the key functionalities of IRSP application that are in-scope for re-engineering?: • Data delivery platform, navigation and collaboration backbone: The IRSP applications cannot work without the third-party platform common library. A new Common Library needs to be built to replace the existing one.

• STS (Security Token Service): This is an ASP.Net website that uses the third-party platforms common Library to provide services to the applications ecosystem, such as user authentication, password reset, API token authentication and token verification. STS is a model for single sign-on authentication.

• CDN (Content Delivery Network):.The current CDN is mostly used for asset version control and server relief from a couple of asset requests.

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